UNDERSTANDING INDIVIDUAL CASE SAFETY REPORT (ICSR) - Qtech-Sol offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Drug Safety
 
Duration:
3 Weeks / 80 Hours
 
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UNDERSTANDING INDIVIDUAL CASE SAFETY REPORT (ICSR)

Introduction – Understanding ICSR

The Individual Case Safety Report (ICSR) is the cornerstone of pharmacovigilance. Every report of an adverse event, whether from a clinical trial or post-marketing source, must be captured, documented, assessed, and submitted in compliance with global regulatory standards.

The ICSR program introduces learners to the fundamentals of case safety reporting, from data collection through assessment and regulatory submission. It equips students and professionals with the knowledge and practical skills to work effectively in drug safety operations, pharmacovigilance case processing, and regulatory reporting roles.

Course Name :  Understanding Individual Case Safety Report (ICSR)
Course Code :  ICSR
Experience Level :  Entry to Mid-Level
Qualification :  Bachelor’s / Master’s in Life Sciences, Pharmacy, Nursing, Medicine, or related fields
Student Category :  Fresh Graduates, Career Changers, PV Associates, Clinical Research Staff

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 3 weeks (80 hours)
  2. Format: Self-Paced Online with Support (presentations, readings, quizzes, and practical case exercises
Key Learning Objectives

   By the end of this course, learners will:

  1. Understand the structure, purpose, and importance of ICSRs in pharmacovigilance.
  2. Learn the minimum criteria for a valid ICSR (identifiable patient, identifiable reporter, suspect product, and event).
  3. Gain knowledge of data elements included in an ICSR (patient demographics, medical history, event description, outcomes, treatments).
  4. Recognize sources of ICSRs: clinical trials, spontaneous reports, literature, registries, and health authority databases.
  5. Explore regulatory guidelines for ICSR submission (FDA, EMA EudraVigilance, ICH E2B).
  6. Understand the process of narrative writing within ICSR documentation.
  7. Learn about duplicate management, coding (MedDRA, WHO-DD), and data quality checks.
  8. Review real-world case examples to practice identification, processing, and reporting.
Who Should Take This Course
  1. Drug Safety / PV Associates involved in case processing.
  2. Clinical trial professionals transitioning into PV.
  3. Healthcare professionals (pharmacists, nurses, physicians) interested in regulatory reporting.
  4. Career changers from life sciences aiming to build PV skills.
Benefits & Outcomes
  1. Build competency in safety case reporting and regulatory submissions.
  2. Learn how to write narratives and perform data entry in PV databases.
  3. Understand compliance with global PV regulations and reporting timelines.
  4. Be job-ready for roles such as Drug Safety Associate, Case Processor, ICSR Specialist, or PV Coordinator.
Career Pathways: After completing this course
  1. Drug Safety Case Processor
  2. ICSR Specialist
  3. Pharmacovigilance Associate
  4. Adverse Event Data Analyst
  5. Clinical Safety Coordinator

Curriculum & Modules

Modules
1. Introduction to ICSR in Pharmacovigilance

2. Minimum Criteria for a Valid ICSR

3. Core Data Elements of an ICSR

4. Sources of ICSRs: Clinical & Post-Marketing

5. Regulatory Guidelines & ICH-E2B Submissions

6. Basics of MedDRA & WHO-DD Coding for ICSRs

7. Narrative Writing for ICSRs

8. Duplicate Case Management & Quality Checks

9. ICSR Workflow: Collection → Entry → QC → Reporting

10. Case Studies & Practical Scenarios
Getting in Touch:

For more information, please call us at +91 8925971788 / +91 8977943100 (WhatsApp)or email qpdc@qtechelearncenter.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.